Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)

Inclusion Criteria: Must have a confirmed diagnosis of HCC by imaging confirmation with Liver Imaging Reporting and Data System (LIRADS) category 5 or confirmation of HCC via biopsy. No extra hepatic disease. Up to 3 lesions with at least one lesion ≥ 2 cm in diameter (long axis) measurable by computed tomography (CT), CBCT, or MRI. At least one lesion must be identified as a target lesion as defined by mRECIST. Maximal single lesion size of ≤ 8 cm and sum of the maximal tumor dimensions of ≤ 12 cm with the entire tumor burden expected to be treatable within the perfused volume. Intent to treat all lesions within a single session. Hypervascular on CBCT, CT, or MRI. Evidence that > 33% of the total liver volume is disease-free and will be spared Eye90 treatment. Life expectancy of ≥ 6 months. ≥ 18 years old at the time of informed consent Exclusion Criteria: Platelet count <50,000/microliter or prothrombin (PT) activity > 50% normal. Hemoglobin ≤ 8.5 g/dL (subjects that are non-responders to transfusion or medical management must be excluded). INR > 1.7 (if anticoagulated, reversal must be achieved prior to any angiographic procedures). ALT > 5x upper limit. AST > 5x upper limit. Bilirubin ≥ 2.0 mg/dL. eGFR ≤ 50 mL/min/BSA. Macrovascular invasion. Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater. Estimated lung dose > 30 Gy as calculated using the lung shunt fraction and partition model.